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Behavioural Intervention
Theta-Burst Stimulation for Opioid Addiction
N/A
Waitlist Available
Led By Nolan R Williams, MD
Research Sponsored by Stanford University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Failed at least one anti-depressant trial (>/=6 week duration at an effective dose)
Over 18 at the time of screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up after all stimulation sessions have been completed (approximately 48 hours after the final session)
Awards & highlights
Study Summary
This trial will test whether a new type of brain stimulation can help people with opiate addiction by reducing cravings and depression.
Who is the study for?
This trial is for adults over 18 with Opioid Use Disorder who are in good health, have a negative drug test, and if female, use effective birth control. They must be registered with a psychiatrist, on stable mental health treatment for 6+ weeks, and have failed at least one antidepressant trial. Excludes those with autism, low IQ, movement disorders, mania or psychosis history, recent substance use other than opioids or intoxication.Check my eligibility
What is being tested?
The study tests whether accelerated intermittent theta-burst stimulation (aiTBS), a non-invasive brain stimulation technique can reduce depression symptoms and opioid cravings in people with Opioid Use Disorder. It also examines changes in brain connectivity related to the effectiveness of aiTBS.See study design
What are the potential side effects?
While not explicitly listed here, common side effects of TMS may include headache or discomfort at the stimulation site; rare risks include seizures or hearing loss without ear protection during treatment.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have tried an antidepressant for 6 weeks or more without success.
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I am over 18 years old.
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I have been on stable mental health treatment for 6 weeks and plan to continue.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ after all stimulation sessions have been completed (approximately 48 hours after the final session)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~after all stimulation sessions have been completed (approximately 48 hours after the final session)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Beck Scale for Suicidal Ideation (SSI) score
Secondary outcome measures
Change in Beck Depression Inventory II (BDI-II) score
Change in Columbia Suicide Severity Scale (C-SSRS) score
Change in Montgomery Asberg Depression Rating Scale (MADRS) score
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Left DLPFC aiTBS stimulationExperimental Treatment1 Intervention
Participants will receive aiTBS (intermittent theta burst stimulation) to a brain area called the left dorsolateral prefrontal cortex (L-DLPFC). Stimulation intensity will be individualized according to the individual's resting motor threshold.
Group II: ACC aiTBS stimulationExperimental Treatment1 Intervention
Participants will receive aiTBS (intermittent theta burst stimulation) to a brain area called the anterior cingulate cortex (ACC). Stimulation intensity will be individualized according to the individual's resting motor threshold.
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Who is running the clinical trial?
Stanford UniversityLead Sponsor
2,396 Previous Clinical Trials
17,341,525 Total Patients Enrolled
Nolan R Williams, MDPrincipal InvestigatorStanford University
Gregory Sahlem, MDPrincipal InvestigatorStanford University
7 Previous Clinical Trials
262 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have tried an antidepressant for 6 weeks or more without success.You have problems with thinking or memory, including dementia.I have a condition that affects my movement.I have a history of epilepsy or seizures.You are currently experiencing an uncontrollable mental illness.My IQ is below 70.I am experiencing withdrawal symptoms from alcohol or benzodiazepines.The principal investigator thinks there are other reasons that would make the data unreliable.You have been diagnosed with Opiate Use Disorder according to a book called Diagnosis and Statistical Manual of Mental Disorders.I am currently experiencing a manic episode.You have a medical condition that could be risky or affect the accuracy of the study results, according to the investigator.I am either not able to have children or am using effective birth control.You have metal fragments or objects in your head.I usually sleep at least 5 hours each night.I am over 18 years old.You are able to handle the medical procedures involved in the study.You have a metal device in your brain, such as a deep brain stimulator, a pacemaker in your heart, or a cochlear implant.You have been diagnosed with Autism Spectrum Disorder.I have been on stable mental health treatment for 6 weeks and plan to continue.You are pregnant.
Research Study Groups:
This trial has the following groups:- Group 1: ACC aiTBS stimulation
- Group 2: Left DLPFC aiTBS stimulation
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Opioid Use Disorder Patient Testimony for trial: Trial Name: NCT03804619 — N/A
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there currently any open slots for participation in this experiment?
"Unfortunately, the data on clinicaltrials.gov indicates that this particular medical trial is no longer seeking enrolment from potential test subjects. This study was initially posted on January 1st of 2023 and last updated on October 24th 2022; however, there are over two-thousand other studies actively recruiting now."
Answered by AI
Who else is applying?
What state do they live in?
Nevada
California
What site did they apply to?
Stanford University
What portion of applicants met pre-screening criteria?
Met criteria
Did not meet criteria
How many prior treatments have patients received?
3+
0
Why did patients apply to this trial?
I have been taking opioids for pain and now can't seem to stop. I have had a past drug problem with meth but haven't used since meth since 2003.
PatientReceived 1 prior treatment
I have tried multiple western medicine treatments along with other homeopathic and psychedelic treatments such Ayawaska, Microdosing psilocybin and ketamine to help with my depression, opiate use and suicidal tendencies. Some have helped aid certain symptoms but never all of them equally. One of my symptoms usually come as package deal. Sometimes it starts with the suicidal thoughts and then the continuation of those leads to depression which leads to me self medicating.
PatientReceived 2+ prior treatments
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